UK MHRA Scientific Advice on Pivotal Trial of NG11-2, a Novel Product for the Prevention of Oral Mucositis
20th -June- 2025
VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, is pleased to announce that the company has received supportive feedback from the MHRA on the approach to a pivotal Phase 2b/3 trial and market approval for NG11-2, a novel product for the prevention of severe oral mucositis induced by radiotherapy. The written scientific advice covered clinical and regulatory questions and market approval approaches.
Dr Ningfeng Fiona Li, CEO of VasoDynamics, said:
“We are delighted to receive the supportive Scientific Advisory feedback from MHRA. We greatly appreciate the valuable advice on the protocol design for the NG11-2 pivotal trial and how to approach market approval filings. We have also received scientific advice from MEB in the Netherlands, where VasoDynamics is establishing a subsidiary. With communication expected later this year from the EMA and FDA, we are building a clear roadmap to bring NG 11-2 to patients and the market in an optimal manner.”
For enquiries, please contact:
Dr Ningfeng Fiona Li, CEO
fiona.li@vasodynamics.co.uk
Notes to Editors:
About VasoDynamics
VasoDynamics is a pharmaceutical development company based in Stevenage-London, UK. It is a clinical stage biopharma company with experienced and culture-diversified executives who have shared vision to improve the standard of cancer care globally. Recognising the mounting cost pressures facing healthcare payers all over the world, the company is developing a number of cost-effective medicines, all of which target the prevention of debilitating and often dose-limiting complications of cancer therapy, such as chemotherapy and radiotherapy induced mucositis, dermatitis, and hair-loss. We take great pride in our culture of scientific and development rigour, and our programmes are based on scientific finding and innovations from world-leading research bodies. The company’s proprietary technology platform utilises the different dynamics of normal and cancerous vasculatures developing a serials of pipeline products for various types of cancer patient cohorts, hence to achieve the most effective and patient friendly protections to prevent severe side-effects during various types of cancer treatments.